COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery. (PARAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082744
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : March 19, 2015
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ropivacaine + Sufentanil Drug: Ropivacaine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.
Study Start Date : March 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Continuous paravertebral block with ropivacaine Drug: Ropivacaine
Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Experimental: Continuous paravertebral block with ropivacaine and sufentanil Drug: Ropivacaine + Sufentanil
Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Primary Outcome Measures :
  1. morphine consumption during the first 48 hours [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Acute pain [ Time Frame: 48 hours ]
    using the Visual Analogue Scale (VAS) score

  2. Biological measurements [ Time Frame: 48 hours ]
    Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate

  3. Patient satisfaction [ Time Frame: 48 hours ]
  4. Chronic pain [ Time Frame: 3 and 6 monthes ]
    assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient scheduled for planned video-assisted thoracic surgery
  • Patient that consent to participate
  • Planned placement of paravertebral catheter
  • Patient having a medical insurance

Exclusion Criteria:

  • Patient less than 18 years
  • Refusal to participate
  • Known pregnancy
  • Known allergies to local anesthetics, sufentanil and /or to iodinated contrast material
  • Intolerance to sufentanil and/or morphine
  • Chronic consumption of opiates
  • Preoperative chronic pain syndrome
  • Patient having a contraindication to placement of paravertebrtal catheter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082744

Layout table for location information
Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Layout table for investigator information
Principal Investigator: Christian BAUER, MD Hospices Civils de Lyon, Hopital Louis Pradel
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon Identifier: NCT01082744    
Other Study ID Numbers: 2009.558
2009-014832-38 ( EudraCT Number )
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by Hospices Civils de Lyon:
Paravertebral Block
Regional Anesthesia
Anesthetics Local
Pain Postoperative
Chronic Pain
Thoracic Surgery Video-Assisted.
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General